Synopsis
0
VMF
0
Australia
Annual Reports
NA
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. D-methorphan
2. Dextromethorphan
3. Dextromethorphan Hydrobromide
4. Dextromethorphan Hydrobromide, (+-)-isomer
5. Dextromethorphan Hydrobromide, Monohydrate
6. Dextromethorphan Hydrochloride
7. Dextromethorphan, (+-)-isomer
8. Hydrobromide, Dextromethorphan
9. Hydrochloride, Dextromethorphan
10. L-methorphan
11. Levomethorphan
12. Racemethorphan
1. Dextromethorphan Hydrobromide
2. 125-69-9
3. Antussan
4. Demorphan
5. Dormethan
6. Metrorat
7. Medicon
8. Tusilan
9. Tussade
10. D-methorphan Hydrobromide
11. Romilar
12. Methorate Hydrobromide
13. Dextromethorphan Bromide
14. Dextromethorphan (hydrobromide)
15. Dextromethorphan Hydrobromide Anhydrous
16. Ro 1-5470/5
17. Dextromethorphan Hbr
18. D-3-methoxy-n-methylmorphinan Hydrobromide
19. Z0cg3115fg
20. Benylin Dm
21. (1s,9s,10s)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide
22. Romilar Hydrobromide
23. (9?,13?,14?)-3-methoxy-17-methylmorphinan Hydrobromide
24. Dextroramin P
25. Demorphine
26. Dextrometorphan Hydrobromide
27. Allfen-dm
28. (1s,9s,10r)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide
29. Nsc-756723
30. Demorphan Hydrobromide
31. Einecs 204-750-1
32. Dextromethorphan Polistirex
33. (9alpha,13alpha,14alpha)-3-methoxy-17-methylmorphinan Hydrobromide
34. Unii-z0cg3115fg
35. Canfodion
36. Cosylan
37. Dormetan
38. Hihustan M.
39. Ro 1-5470
40. Dxm Hbr
41. 9-alpha,13-alpha,14-alpha-morphinan, 3-methoxy-17-methyl-, Hydrobromide
42. Schembl121924
43. Morphinan, 3-methoxy-n-methyl-, Hydrobromide, (+)-
44. Chembl1201004
45. Dtxsid60872346
46. Bcp06595
47. Hy-b0620
48. Dextromethorphan Hbr Anhydrous
49. Mfcd00269810
50. Akos022186323
51. Ccg-212567
52. Nsc 756723
53. Dextromethorphan Hydrobromide [mi]
54. Dextromethorphan Hydrobromide [who-dd]
55. Q27294835
56. (9alpha,13alpha,14alpha)-3-methoxy-17-methylmorphinan Hbr
57. 3-methoxy-17-methyl-9.alpha.,13.alpha.,14.alpha.-morphinan Hbr
58. Morphinan, 3-methoxy-17-methyl-, (9alpha,13alpha,14alpha)-, Hydrobromide
59. 3-methoxy-17-methyl-9.alpha.,13.alpha.,14.alpha.-morphinan Hydrobromide
60. 9alpha,13alpha,14alpha-morphinan, 3-methoxy-17-methyl-, Hydrobromide (8ci)
61. Morphinan, 3-methoxy-17-methyl-, (9.alpha.,13.alpha.,14.alpha.)-, Hbr
62. Morphinan, 3-methoxy-17-methyl-, (9.alpha.,13.alpha.,14.alpha.)-, Hydrobromide
63. Morphinan, 3-methoxy-17-methyl-, Hydrobromide (1:1),(9.alpha.,13.alpha.,14.alpha.)-
64. (4bs,8as,9s)-3-methoxy-11-methyl-6,7,8,8a,9,10-hexahydro-5h-9,4b-(epiminoethano)phenanthrene Hydrobromide
65. 1887136-04-0
Molecular Weight | 352.3 g/mol |
---|---|
Molecular Formula | C18H26BrNO |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 1 |
Exact Mass | 351.11978 g/mol |
Monoisotopic Mass | 351.11978 g/mol |
Topological Polar Surface Area | 12.5 Ų |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 370 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Delsym |
Active Ingredient | Dextromethorphan polistirex |
Dosage Form | Suspension, extended release |
Route | Oral |
Strength | eq 30mg hbr/5ml |
Market Status | Over the Counter |
Company | Reckitt Benckiser |
2 of 4 | |
---|---|
Drug Name | Dextromethorphan polistirex |
Active Ingredient | Dextromethorphan polistirex |
Dosage Form | Suspension, extended release |
Route | Oral |
Strength | eq 30mg hbr/5ml |
Market Status | Over the Counter |
Company | Tris Pharma |
3 of 4 | |
---|---|
Drug Name | Delsym |
Active Ingredient | Dextromethorphan polistirex |
Dosage Form | Suspension, extended release |
Route | Oral |
Strength | eq 30mg hbr/5ml |
Market Status | Over the Counter |
Company | Reckitt Benckiser |
4 of 4 | |
---|---|
Drug Name | Dextromethorphan polistirex |
Active Ingredient | Dextromethorphan polistirex |
Dosage Form | Suspension, extended release |
Route | Oral |
Strength | eq 30mg hbr/5ml |
Market Status | Over the Counter |
Company | Tris Pharma |
Excitatory Amino Acid Antagonists
Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)
Antitussive Agents
Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33575
Submission : 2019-03-25
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-6500
Start Marketing Date : 2017-01-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-28
Pay. Date : 2019-04-25
DMF Number : 32402
Submission : 2018-01-04
Status : Active
Type : II
Certificate Number : CEP 2018-133 - Rev 02
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 20
Status : Valid
NDC Package Code : 57218-760
Start Marketing Date : 2017-02-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-23
Pay. Date : 2024-08-19
DMF Number : 39295
Submission : 2024-01-23
Status : Active
Type : II
Available Reg Filing : ASMF |
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33575
Submission : 2019-03-25
Status : Active
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-28
Pay. Date : 2019-04-25
DMF Number : 32402
Submission : 2018-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-23
Pay. Date : 2024-08-19
DMF Number : 39295
Submission : 2024-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-11-23
DMF Number : 12356
Submission : 1997-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3846
Submission : 1980-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 395
Submission : 1960-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7526
Submission : 1988-06-13
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-16
Pay. Date : 2013-05-09
DMF Number : 11935
Submission : 1996-04-18
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 823
Submission : 1964-07-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8535
Submission : 1990-04-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Japanese Pharmacopoeia Dextromethorphan Hydrobromide Hydrate
Registration Number : 220MF10121
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2008-04-28
Latest Date of Registration : 2022-10-05
Dextromethorphan hydrobromide hydrate
Registration Number : 302MF10047
Registrant's Address : No. 8 Mysun Street, Hongshan Economic Development Zone, Chifeng, Inner Mongolia, Chin...
Initial Date of Registration : 2020-04-17
Latest Date of Registration : 2020-04-17
Japanese Pharmacopoeia Dextromethorphan Hydrobromide (for manufacturing purposes only)
Registration Number : 217MF10567
Registrant's Address : Divi Towers, 7-1-77/E/1/303, Dharam Karan Road, Ameerpet, Hyderabad-500 016, India
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2006-12-27
Japanese Pharmacopoeia Dextromethorphan Hydrobromide Hydrate
Registration Number : 219MF10119
Registrant's Address : Grenzacherstrasse 124, 4070 Basel, Switzerland
Initial Date of Registration : 2007-03-23
Latest Date of Registration : 2007-03-23
Registration Number : 218MF10104
Registrant's Address : Grenzacherstrasse 124, 4070 Basel, Switzerland
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2006-09-22
Dextromethorphan hydrobromide hydrate
Registration Number : 220MF10108
Registrant's Address : Wockhardt Towers, Bandra-kurla Complex, Bandra (East), Mumbai-400 051, Maharashtra, I...
Initial Date of Registration : 2008-04-11
Latest Date of Registration : 2008-04-11
Dextromethorphan hydrobromide hydrate
Registration Number : 303MF10152
Registrant's Address : Wockhardt Towers, Bandra-kurla Complex, Bandra (East), Mumbai-400 051, Maharashtra, I...
Initial Date of Registration : 2021-09-28
Latest Date of Registration : 2021-09-28
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
CAS Number : CAS-30356-07-1
End Use API : Dextromethorphan Hydrobromide
About The Company : Shreeneel Chemicals is dedicated to quality healthcare development and fostering a knowledgeable environment. The company was founded by Mr. Sanjay Tavethiya an...
CAS Number : CAS-30356-07-1
End Use API : Dextromethorphan Hydrobromide
About The Company : Venkata Narayana Active Ingredients (Formerly Nutra Specialties Private Limited) Promoted by a well-known business house of India, Mr. Abhaya Kumar Jain who has...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AA
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form : SYRUP;ORAL
Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML
Approval Date : 2018-12-04
Application Number : 207676
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG;600MG
Approval Date : 2023-08-01
Application Number : 217340
RX/OTC/DISCN : OTC
RLD : No
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG;1.2GM
Approval Date : 2023-08-01
Application Number : 217340
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : BROMANATE DM
Dosage Form : SYRUP;ORAL
Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML
Approval Date : 1985-03-07
Application Number : 88722
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AA
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Brand Name : BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form : SYRUP;ORAL
Dosage Strength : 2MG/5ML;10MG/5ML;30MG/5ML
Approval Date : 2020-07-14
Application Number : 210647
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code :
Brand Name : DEXTROMETHORPHAN POLISTIREX
Dosage Form : SUSPENSION, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 30MG HYDROBROMIDE/5ML
Approval Date : 2017-07-28
Application Number : 203133
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 30MG;600MG
Approval Date : 2018-11-01
Application Number : 209692
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Brand Name : GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : 60MG;1.2GM
Approval Date : 2018-11-01
Application Number : 209692
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Brand Name : PROMETH W/ DEXTROMETHORPHAN
Dosage Form : SYRUP;ORAL
Dosage Strength : 15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1984-10-31
Application Number : 88762
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD :
TE Code :
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Brand Name : DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 20MG;10MG
Approval Date :
Application Number : 202993
RX/OTC/DISCN :
RLD :
TE Code :
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
65
PharmaCompass offers a list of Dextromethorphan Hydrobromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dextromethorphan Hydrobromide manufacturer or Dextromethorphan Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dextromethorphan Hydrobromide manufacturer or Dextromethorphan Hydrobromide supplier.
PharmaCompass also assists you with knowing the Dextromethorphan Hydrobromide API Price utilized in the formulation of products. Dextromethorphan Hydrobromide API Price is not always fixed or binding as the Dextromethorphan Hydrobromide Price is obtained through a variety of data sources. The Dextromethorphan Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dextromethorphan Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextromethorphan Hydrobromide, including repackagers and relabelers. The FDA regulates Dextromethorphan Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextromethorphan Hydrobromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Dextromethorphan Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextromethorphan Hydrobromide supplier is an individual or a company that provides Dextromethorphan Hydrobromide active pharmaceutical ingredient (API) or Dextromethorphan Hydrobromide finished formulations upon request. The Dextromethorphan Hydrobromide suppliers may include Dextromethorphan Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Dextromethorphan Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextromethorphan Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextromethorphan Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Dextromethorphan Hydrobromide DMFs exist exist since differing nations have different regulations, such as Dextromethorphan Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dextromethorphan Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Dextromethorphan Hydrobromide USDMF includes data on Dextromethorphan Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextromethorphan Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dextromethorphan Hydrobromide suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dextromethorphan Hydrobromide Drug Master File in Japan (Dextromethorphan Hydrobromide JDMF) empowers Dextromethorphan Hydrobromide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dextromethorphan Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Dextromethorphan Hydrobromide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dextromethorphan Hydrobromide suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dextromethorphan Hydrobromide Drug Master File in Korea (Dextromethorphan Hydrobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dextromethorphan Hydrobromide. The MFDS reviews the Dextromethorphan Hydrobromide KDMF as part of the drug registration process and uses the information provided in the Dextromethorphan Hydrobromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dextromethorphan Hydrobromide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dextromethorphan Hydrobromide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dextromethorphan Hydrobromide suppliers with KDMF on PharmaCompass.
A Dextromethorphan Hydrobromide CEP of the European Pharmacopoeia monograph is often referred to as a Dextromethorphan Hydrobromide Certificate of Suitability (COS). The purpose of a Dextromethorphan Hydrobromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dextromethorphan Hydrobromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dextromethorphan Hydrobromide to their clients by showing that a Dextromethorphan Hydrobromide CEP has been issued for it. The manufacturer submits a Dextromethorphan Hydrobromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dextromethorphan Hydrobromide CEP holder for the record. Additionally, the data presented in the Dextromethorphan Hydrobromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dextromethorphan Hydrobromide DMF.
A Dextromethorphan Hydrobromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dextromethorphan Hydrobromide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Dextromethorphan Hydrobromide suppliers with CEP (COS) on PharmaCompass.
A Dextromethorphan Hydrobromide written confirmation (Dextromethorphan Hydrobromide WC) is an official document issued by a regulatory agency to a Dextromethorphan Hydrobromide manufacturer, verifying that the manufacturing facility of a Dextromethorphan Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dextromethorphan Hydrobromide APIs or Dextromethorphan Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Dextromethorphan Hydrobromide WC (written confirmation) as part of the regulatory process.
click here to find a list of Dextromethorphan Hydrobromide suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dextromethorphan Hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dextromethorphan Hydrobromide API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Dextromethorphan Hydrobromide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Dextromethorphan Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dextromethorphan Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dextromethorphan Hydrobromide suppliers with NDC on PharmaCompass.
Dextromethorphan Hydrobromide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Dextromethorphan Hydrobromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dextromethorphan Hydrobromide GMP manufacturer or Dextromethorphan Hydrobromide GMP API supplier for your needs.
A Dextromethorphan Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Dextromethorphan Hydrobromide's compliance with Dextromethorphan Hydrobromide specifications and serves as a tool for batch-level quality control.
Dextromethorphan Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Dextromethorphan Hydrobromide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Dextromethorphan Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Dextromethorphan Hydrobromide EP), Dextromethorphan Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dextromethorphan Hydrobromide USP).